Cleared Traditional

K041486 - VASOSTASIS VASCULAR CLOSURE SYSTEM

K041486 is an FDA 510(k) clearance for VASOSTASIS VASCULAR CLOSURE SYSTEM, manufactured by Cardiva Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K041486 · Cardiva Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
140d
Days
Class 2
Risk

K041486 is an FDA 510(k) clearance for the VASOSTASIS VASCULAR CLOSURE SYSTEM. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Cardiva Medical, Inc. (Pleasanton, US). The FDA issued a Cleared decision on October 22, 2004 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K041486

510(k) Number K041486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2004
Decision Date October 22, 2004
Days to Decision 140 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 193
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K041486.
SYVEKEXCEL
K053300 · Marine Polymer Technologies, Inc. · Mar 2006
COMPASS COMPRESSION ASSIST HANDLE
K053398 · Semler Technologies, Inc. Dba · Mar 2006
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K050146 · Vascular Solutions, Inc. · May 2005
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · Vascular Solutions, Inc. · Jun 2004
COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
K040615 · Advanced Vascular Dynamics · Jun 2004
PORTACLAMP
K033085 · Cardio Life Research, S.A. · Apr 2004
K041486 · VASOSTASIS VASCULAR CLOSURE SYSTEM
Download PDF FDA Summary Cardiva Medical, Inc.